28-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension

Phase 1

Completed

• Conditions: Open Angle Glaucoma -Ocular Hypertension
• Interventions: Drug: SAR366234; Drug: Latanoprost

• Registration Number: NCT02531152
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To assess the local and systemic safety and tolerability of ascending repeated topical doses of SAR366234 monotherapy in patients with open angle glaucoma (OAG) or ocular hypertension (OHT) as compared to latanoprost.

Secondary Objective:

To assess the pharmacodynamic activity of ascending repeated topical doses of SAR366234 in patients with OAG or OHT as compared to latanoprost.

Detailed Description

The total study duration for one patient is up to 11 weeks, including a screening period of up to 6 weeks run-in (depending on washout requirements), a 4-week treatment period, and a 1-week follow-up period.

The study design is also a parallel cohort study to assess the safety, tolerability, and pharmacodynamic activity of SAR366234.

Study Timeline

• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-24
• Study Start: 2015-09
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAR366234 (Dose 1)	SAR366234	A low dose of SAR366234 will be administered 2 drops per eye per day for 28 days
SAR366234 (Dose 2)	SAR366234	A medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days
SAR366234 (Dose 3)	SAR366234	A medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days
Latanoprost	Latanoprost	A dose of Latanoprost will be administered 1 drop per eye per day for 28 days
SAR366234 (Dose 4)	SAR366234	A high dose of SAR366234 will be administered 1 drop per eye per day for 28 days
SAR366234 (Dose 5)	SAR366234	A high dose of SAR366234 will be administered 2 drops per eye per day for 28 days

Primary Outcome Measures

Name	Time	Method
Number of adverse events (including local tolerance and ophthalmological examinations)	From screening (Day -42) up to approximately Day 39

Secondary Outcome Measures

Name	Time	Method
Assessment of IOP using Goldman applanation tonometry	From screening (Day -42) up to approximately Day 39

Trial Locations

Locations (5)

Investigational Site Number 840001; 🇺🇸 Inglewood, California, United States

Investigational Site Number 840005; 🇺🇸 Roswell, Georgia, United States

Investigational Site Number 840004; 🇺🇸 St Joseph, Michigan, United States

Investigational Site Number 840003; 🇺🇸 Cape Coral, Florida, United States

Investigational Site Number 840002; 🇺🇸 Memphis, Tennessee, United States